Human Gene Patents - Essay Example

Gene Patenting A gene patent is a patent on a particular gene sequence, on its chemical and structural composition, on the processes of obtaining it and aggregation of such claims. Gene patents are subset of a wider category of biological patents. Patents are granted only on specific isolated genes whose function is known. There are many benefits to gene patenting but there are also some controversies to its use. The United States Patent and Trademark Office (USPTO) regulates the patenting of genes and gene product (Barton, pg121-125). It has issued patents for a few gene fragments. Expressed sequence tags (ESTs) with 300 to 500 base gene fragments, represent about only 10 to 30% of the average cDNA. cDNA is a laboratory synthesized DNA that contains only exons in their fragment. These allow the genetic researchers to limit their research to only information containing gene fragments. Patenting of gene fragments has sparked controversy. This is because researchers feel that allowing many patents on gene fragments of same genome adds up to costs to the researcher who is interested in examining the whole genome. The researcher will not only have to pay to each patent holder in order to get an opportunity to study each gene fragment, the researcher will also have to pay the people he has hired to study different patented genes and determine which genes are applicable for his research. Variation in DNA sequences when a single nucleotide in the gene is altered is known as single nucleotide polymorphism (SNPs). For instance, SNP might alter a DNA sequence GATCAATA to GAACAATA. Along the human genome, SNPs occur after every 100 to 1000 bases. They can occur in both coding part of the gene as well as non-coding part of the gene. Normally, SNPs have no affect on function of cells, but researchers believe that some SNPs can make people more likely to contract a disease or affect their response to a drug. Difference in genomic sequences influences how humans respond to different diseases, environmental dangers like that of viruses, bacteria, chemicals and toxins and drug therapies. These variations make SNPs of great importance for making researches in field of biomedical and for developing different pharmaceutical products. Researchers believe that SNPs will help them identify the affects of different genes that contribute towards complicated diseases like diabetes, cancer and mental illness. In conventional ways of hunting genes, association between genes and diseases is difficult to make because an altered gene makes a very small contribution towards the disease. U.K Wellcome Trust philanthropy and ten big pharmaceutical companies in 1999, established a non-profit organization which would find about 300,000 common SNPs. The foundation then planned to patent all the SNPs found so that they could prevent others from patenting the same information. The information on SNPs found by the consortium is freely available to researchers. Production of human embryos or cloning embryos for use in research is known as 'embryo cloning'. This process clones human embryos in laboratory so that stem cells can be harvested from them and used to study human diseases and development. Stem cells are of great potential to researchers because they can be used to generate any type of specialized cell in the body. Genetically modified organisms and cell lines are patentable material. Patents for cell lines from monkeys and other organisms have already been issued. Thus, based on previous court rulings, embryonic stem cells are patentable. Many controversies have developed regarding the patentability of human embryonic stem cells. The major controversy is that patents for human cell lines and cloning violate the principle of owning human beings. In the US, patents are granted according to a set technical criterion. Ethical issues have not yet influenced this process but it is yet to be seen how stem cell debate change this. Various research groups are patenting genes these days. Most of these gene patenting are done by biotechnology companies but universities are now also getting involved in patenting genes. For instance, University of California holds patents to many gene related products (Bonetta, pg 115-116). The National Institute of Health is also joining the scramble for patents (Bonetta, pg 115-116). The inclusion of universities in the race to patent genes, show the rising importance of patent genes and the consequences of not having access to genes and their related products. Gene patents are allowed because it provides benefits to the patentee. The gene patents can provide researchers with an incentive and encourage them to undertake research. The researches undertaken to conduct studies are expensive, and researchers need a way through which they can cover up for the expenses they bore to conduct the study. Licensing fees and patents provide a means for research companies to regain some of the money they have spent on research (Hill, pp221-259). In this way patents can prevent and protect against market failure and foster innovation (Walpole, Dawkins, Sinden, O' Leary,pp 203-205). Funds generated by patents can then be reinvested for further studies. Gene patenting is important because it encourages sharing of information and innovation (Walpole et al pp 203-205). After granting a patent to an innovation, the innovation becomes available to public ('Patents, Medicine pp 1051-1055). This sharing of information prevents the researchers from using the information for their own benefit. This required sharing of information provides other researchers and companies with relevant information on which they can research further. Patenting of genes and their products substantially reduce the chance of wasteful and useless duplicative studies. The duplicative research reduction can occur in two ways. First, it can prevent the production of duplicative drugs, which may be considered wasteful. Second, it can prevent researchers from doing research on the same product. The company that holds patent for a gene restricts who does research on that patent gene and ensure that multiple companies are not doing research on the same gene (Hill pg 221-259). There have also been controversies to this argument. Duplicative studies are considered part of scientific process that ensures that the original research was done correctly and that the same result is reached. If several institutions work on the same gene, product is developed faster than only a single company focusing on the gene. In the case of drugs, if many companies are working on making different variants of a single drug, then probably a more effective and cheaper drug can be developed. Thus, duplicative studies are beneficial or general public if not for the companies owing patents of the genes. The use of gene patents is widely defended as a means of free enterprise (Patents , Medicine pp 1051-1055). It is argued that as researcher puts in all his efforts to create something, he/she deserves to reap benefits from his/her discovery. This supports the idea of licensing fees and limited access to the discovery. In this understanding, gene patents and drug discovery are considered to be like any other business that encourages gain of profit from endeavors. This idea is perceived as harsh when considering the fact that some of the patent genes can directly affect the human health. There are also many problems related to gene patenting. One of the major arguments against gene patenting is that genes should not be patented at all. The American College of Medical Genetics in 1999, issued a position paper stating that no naturally occurring gene should be patented because they occur naturally. Many people believe that isolated gene fragments are not different from the genes that are found in human body and thus should not be allowed for patenting. Council for Responsible Genetics, in March 200 requested the exclusion of human genes from patent system (Dahl, pp A31-A33). Since genes are found in every human being, many people feel patenting of human genes as personal violation. Another problem with gene patenting is that it can actually prevent sharing of information about gene or its related product. If a company has made a discovery, then it cannot hope to release the information until it receives patent for its discovery. If a company reports its findings beforehand, then the discovery would be considered as 'prior art' and would then be not available for patenting (Dahl, A31-33). This means that in order to receive patent, the companies must keep their discoveries as a secret until they receive a patent. The patenting process takes about 18 months, which means the discovery may not be disclosed until a year and a half after the discovery was made (Hill, 221-259). This delay could prove to be potentially crucial as many genes and their products are closely related to human health and delay could prevent transmission of important knowledge that could be helpful for health of people. Works Cited 1.Barton, J. (2002). Research-tool patents: issues for health in the developing world. Bulletin of the World Health Organization, 80, 121-125. 2.Bonetta, L. (2001). Raising the bar for gene patents. Current Biology, 11 (4), R115-R116. 3.Hill, L. (2003). The race to patent the genome: free riders, hold ups, and the future of medical breakthroughs. Texas Intellectual Property Law Journal, 11, 221-259. 4. Patents, medicine, and the interests of patients: applying general principles to gene patentin (2002). The American College of Obstetricians and Gynecologists, 100 (5), 1051-1055. 5. Walpole, I., Dawkins, H., Sinden, P., and O'Leary, P. (2003). Human gene patents: the possible impacts on genetic services healthcare. MJA, 179 (4), 203-205. Read More